FDA Device recall Z-0030-2020
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path
- FDA Device
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path by Baxter Healthcare, citing potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0030-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-10 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | CA, DC, DE, FL, GA, MD, NC, NV, PA, SC, TX, VA, WA |
Product
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Reason
Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis.
Identifiers
| code_info | Lot Number H18D22030 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0030-2020%22
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